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. Author manuscript; available in PMC: 2014 Aug 14.
Published in final edited form as: Cancer. 2013 Apr 19;119(14):2611–2619. doi: 10.1002/cncr.28113

Table 3. Adverse events (any grade; any cause) occurring in ≥20% of patients in either arm or grade ≥3 events (any cause) occurring in ≥3 patients.

Adverse event Number of patients, n (%)
Barasertib 1200 mg(n=48) LDAC 400 mg(n=26)
All grades Grade 3 Grade 4 Grade 5 All grades Grade 3 Grade 4 Grade 5
Stomatitis/mucositis 37 (77) 14 (29) 6 (23)
Febrile neutropenia 32 (67) 23 (48) 1 (2) 6 (23) 5 (19)
Diarrhea 24 (50) 2 (4) 3 (12)
Constipation 22 (46) 8 (31)
Nausea 21 (44) 1 (2) 10 (39)
Vomiting 16 (33) 5 (19)
Pyrexia 13 (27) 8 (31)
Pneumonia/lobar pneumonia 12 (25) 7 (15)* 4 (8) 2 (8) 1 (4)* 1 (4)
Alopecia 11 (23) 0
Epistaxis 11 (23) 6 (23)
Anemia 10 (21) 1 (2) 6 (13) 4 (15) 4 (15)
Decreased appetite 10 (21) 5 (19)
Insomnia 10 (21) 3 (12)
Rash 10 (21) 2 (8)
Fatigue 9 (19) 6 (23)
Thrombocytopenia 9 (19) 1 (2) 6 (13) 5 (19) 4 (15)
Back pain 8 (17) 2 (8)
Dyspnea 8 (17) 1 (2) 5 (19) 3 (12) 1 (4)
Hypokalemia 8 (17) 2 (8)
Asthenia 7 (15) 8 (31)
Neutropenia 7 (15) 4 (8) 3 (6) 2 (8) 2 (8)
Edema peripheral 7 (15) 7 (27)
Leukopenia 6 (13) 1 (2) 5 (10)
Cellulitis 4 (8) 4 (8)
Lymphopenia 4 (8) 1 (2) 3 (6)
Sepsis 4 (8) 3 (6) 1 (2) 1 (4)
Hyponatremia 3 (6) 3 (6) 1 (4) 1 (4)
*

Classified as pneumonia only. Stomatitis/mucositis includes oral pain, oropharyngeal pain, mouth ulceration, tongue ulceration, gingivitis, and aphthous stomatitis. Febrile neutropenia includes neutropenic infection, febrile bone marrow aplasia, and neutropenic sepsis